Condoms and other prophylactics and protective devices provide physical barriers against the transmission of bodily fluids or other fluids. A chemical barrier can also be used alone or in conjunction with a condom to prevent such transmission. In some instances, the chemical barriers serve as a supplemental form of protection in the event the physical barrier is breached.
Chemical barriers, such as lubricants, have been employed for a number of applications, including lubrication of elastomeric condoms and lubrication of skin. More recently, lubricants have been designed to take advantage of the heat that is generated when glycerin and/or propylene glycol are dissolved in water. Unfortunately, glycerin and propylene glycol on their own do not spread readily on skin and other surfaces and can irritate skin after prolonged use, since glycerin extracts water from the skin surface. The spreadability of such lubricants is further compromised by the addition of one or more insulating agents, such as honey, isopropyl myristate and/or isopropyl palmitate, which reportedly help to retain the heat of the lubricant see, e.g., Int'l App. Pub. Nos. WO 03/092652, WO 03/092651, and WO 03/092650 (corresponding to U.S. Pat. Nos. 7,005,408, 7,285,517, 7,417,013 (Ahmad); U.S. Pat. App. Pub. Nos. 2003/0211161, 2004/0167039, 2004/0185065, 2005/0042248, 2005/0042249, US2006/0094608, and 2007/0287714 (Ahmad)) discussed below.
Glycerin and propylene-based alcohols have been used in water soluble condom lubricants. For example, U.S. Pat. No. 6,196,227 to Tsushima discloses water soluble lubricant for a condom and a condom spread with said water soluble lubricant. This lubricant is not indicated to have a warming effect upon contact with skin-generated moisture because the lubricant itself contains water. U.S. Pat. Nos. 5,885,591 and 6,139,848 to Ahmad et al. discloses highly lubricious personal lubricant compositions containing one or more polyhydric alcohols, one or more water-soluble polymers derived from cellulose, water, and, optionally, preservatives and alkali metal or alkaline earth metal bases. Since these compositions already contain water, no heating or warming reaction occurs when the lubricant is applied to the body and the glycerin comes in contact with body-generated moisture.
U.S. Pat. No. 5,512,289 to Tseng et al. discloses a spermicidal anti-viral lubricant composition containing a water-soluble polymeric gel matrix comprising a hydroxyalkyl cellulose with an alkylphenoxypolyethoxyethanol spermicide and a solubilizing moiety comprising polyethoxylated castor oil. The use of the alkylphenoxypolyethoxyethanol spermicide prevents collapse of the hydroxyalkyl cellulose gel. The spermicidal composition can be dispersed by use of a pharmaceutically acceptable vehicle, such as water, alcohols, e.g., ethanol, glycerin, propylene glycol, and mixtures thereof. A typical formulation of the spermicidal lubricant can include water 75.50 wt %, glycerin 17.00 wt %, hydroxyethyl cellulose 1.00 wt %, polyvinyl pyrrolidone 0.90 wt %, carboxymethyl cellulose 1.00 wt %, Nonoxynol-9 spermicide 2.00 wt %, polyethoxylated castor oil 2.00 wt %, methylparaben 0.20 wt %, sorbic acid 0.05 wt %, and citric acid 0.35 wt %. Since glycerin and glycol are already dissolved in water, the lubricant does not provide a warming effect.
Warming lubricants that contain glycerin and other polyhydric alcohols are known in the prior art. For example, Int'l App. Pub. Nos. WO 03/092651 and WO 03/092652 to Ahmad et al. (see also U.S. Pat. Nos. 7,005,408 and 7,417,013; U.S. Pat. App. Pub. Nos. 2003/0211161 and 2006/0094608) disclose warming and nonirritating lubricating compositions containing polyhydric alcohols and an insulating agent. The polyhydric alcohol comprises glycerin, alkylene glycol, or a mixture thereof. The alkylene glycol is selected from the group consisting of propylene glycol, butylene glycol and hexalene glycol, whereas the polyethylene glycol is selected from the group consisting of polyethylene glycol 300 and polyethylene glycol 400. The insulating agent is selected from the group consisting of honey, isopropyl myristate and isopropyl palmitate. A warming action is created by the heat released during dissolution of the polyhydric alcohol in water, and the insulating agent retains the heat. All compound selected for addition to the anhydrous warming lubricant are both water and glycol soluble and therefore no particles are present in the warming lubricant.
Spreadable warming lubricants are provided in U.S. Pat. App. Pub. Nos. 2006/0188528 (Chuah) and 2006/0189493 (Chuah). These lubricants are substantially anhydrous, comprising a mixture of glycerin, polyhydric alcohol, and a non-ionic surfactant, and, for a thickened lubricant, a carbomer thickener can be used.
U.S. Pat. App. Pub. No. 2005/0076916 to Barder discloses a condom. The condom has a vasodilator active compound applied to its external surface, preferably disposed towards the open end of the condom to alleviate symptoms associated with female sexual dysfunction. The lubricant used is water-based with a pH in the range of 3 and 5. Thus, the lubricant used is not a warming lubricant.
U.S. Pat. No. 6,840,244 to Kemp discloses condom with an erectogenic composition. The condom has an erectogenic vasodialtor compound immobilised at the head end on the interior condom surface. The erectogenic compound can be dispersed or dissolved in a gel carrier comprising a thickened liquid medium. The condom may also include a lubricant, which is immiscible with the erectogenic compound or composition. The erectogenic compound is not provided as an insoluble particle dispersed in a warming lubricant, but rather it is localized at the head end of the condom. When the lubricant is water based, the thickened liquid medium preferably comprises a vegetable oil, for example castor oil, to achieve immiscibility. When the lubricant is oil based, the medium preferably comprises a polyhydroxy compound such as propylene glycol. The vasodilator is selected from nitrates, long and short acting alpha-adrenoceptor blockers, ergot alkaloids, anti-hypertenives and the prostaglandins. The lubricant is not a warming lubricant.
U.S. Pat. No. 7,405,186 to Harrison discloses lubricant compositions, condom products and methods of making same. The warming lubricant includes about 50% by weight of an anhydrous polyalkylene glycol component, comprising two different molecular weights of polyalkylene glycol, remaining comprising a viscosity inducing cellulosic derivative. It is indicated that the lubricant may comprise vasodilators such as methyl nicotinate or histamine hydrochloride. Both methyl nicotinate and histamine hydrochloride are soluble in both water and alcohols and will not result in an active vasodilator particle dispersed in the warming lubricant due to their solubility therein.
U.S. Pat. No. 6,290,981 to Keefer, et al. discloses the use of nitric oxide-releasing agents to treat impotency. This method involves the administration of nitric oxide by a nitric oxide-releasing agent that can be a polyether comprising at least one nitric oxide-releasing functional group. Also provided are nitric oxide delivery means, such as transurethral applicator, penile implant, dermal patch or condom, for use in the method.
U.S. Pat. No. 7,214,390 to Barone, Jr., et al. discloses topical compositions for enhancing sexual responsiveness. This topical composition enhances sexual responsiveness of a mammal and comprises an effective dosage of a peripheral vasodilator, an absorption enhancer, a vasoconstrictor, an alpha receptor blocker are combined with a pharmaceutically-acceptable topical vehicle to produce the composition. The composition can comprisea) about 1% methyl nicotinate, b) about 25 drops of an alcohol extract of yohimbe, c) about 8 mg/cm3 of L-arginine, d) about 12 drops of an alcohol extract of muira puama, e) about 12 drops of an alcohol extract of catuaba, f) about 12 drops of an alcohol extract of maca, and g) about 12 drops of an alcohol extract of saw palmetto, wherein a) through g) are in a pharmaceutically-acceptable water-based topical vehicle comprising aloe and vitamin E. This water-based composition has no warming effect.
There is a therefore need for an improved condom with a lubricant having greater functionalities and enhanced effects than currently available lubricated condoms.